• Cosentyx is a brand (trade) name for secukinumab, a medication that may be used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and some other conditions.
• Secukinumab (Cosentyx) works by selectively binding to interleukin 17A (IL-17A) which is a pro-inflammatory cytokine produced by T-helper cells. IL-17A mediates innate immunity (natural immunity) to infecting substances and it can also contribute to the development of chronic diseases characterized by inflammation, such as psoriasis and ankylosing spondylitis. Secukinumab stops IL-17A from interacting with the IL-17 receptor, which prevents inflammation.
• Cosentyx belongs to the class of medicines called interleukin inhibitors. It may also be called a human IgG1 monoclonal antibody.

• Cosentyx may be used to reduce symptoms of moderate to severe plaque psoriasis in adults and children over the age of six who require systemic therapy or phototherapy.
• Cosentyx may also to treat active psoriatic arthritis in adults, adolescents, and children 2 years of age and older, and enthesitis-related arthritis in adults and children 4 years of age and older.
• Cosentyx may also be used in adults to treat active ankylosing spondylitis and active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Cosentyx may be used off-label for other conditions such as rheumatoid arthritis.
• Cosentyx inhibits the release of proinflammatory cytokines and chemokines which reduces inflammation.
• After an initial loading dose (which for plaque psoriasis consists of 300mg doses of Cosentyx given every week for five doses), Cosentyx is usually given once a month by subcutaneous injection (under the skin). Cosentyx is usually given as a 300mg dose (two injections) but some people may only require a 150mg dose.
• For other conditions, Cosentyx is usually given as a 150mg dose, with or without loading doses. Higher dosages may be given if there is a lack of response.
• Cosentyx is available in three different preparations: a Sensoready pen, prefilled syringe, and lyophilized powder in a vial for reconstitution. The lyophilized powder for reconstitution is for healthcare provider use only.
• People prescribed Cosentyx can be taught how to self administer the Sensoready pen or prefilled syringe by a healthcare professional.
• Cosentyx has few side effects, although it may increase the risk of infection.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nasopharyngitis is the most common side effect reported with Cosentyx, occurring in 11%-12% of people. Side effects occurring in 1% to 5% of people include diarrhea, upper respiratory tract infection, rhinitis, oral herpes, and pharyngitis.
• Injection site reactions (pain, redness, and swelling at the injection site), nausea, neutropenia (low levels of a type of white blood cell), thrombocytopenia (low platelet levels), and other infections are also common. Urticaria can occur.
• Infections are more likely to occur with Cosentyx because it affects the immune system, reducing its ability to respond to pathogens. The most common infections reported include upper respiratory tract infections, conjunctivitis, tinea, and oral candidiasis, and the rate of infection for Cosentyx in one trial was 28.7% compared to 18.9% of subjects treated with a placebo (an inactive treatment). Serious infections occurred in 0.14% of patients treated with Cosentyx compared to 0.3% of patients treated with placebo. Cosentyx should not be started in people who have symptoms of an infection, and your doctor may decide to discontinue Cosentyx, either temporarily or permanently, if you develop an infection while being administered Cosentyx.
• The vaccination status of all patients should be up to date before administering Cosentyx. Do not administer live vaccines to people receiving Cosentyx. There is a possibility that non-live vaccinations received during a course of Cosentyx may not elicit an immune response sufficient to prevent disease.
• Before starting Cosentyx, your doctor will ask you if you have been exposed to tuberculosis (TB) in the past. They may need to do some further tests and may require you to undertake a course of antibiotics if their investigations show you have been exposed to TB. If you develop symptoms of TB (such as a persistent cough lasting longer than three weeks, chest pain, coughing up blood or sputum), tell your doctor immediately.
• Serious hypersensitivity reactions (such as angioedema and urticaria) have been reported rarely in people administered Cosentyx. A health professional should always administer the first dose of Cosentyx and patients should be advised to seek urgent emergency help if they experience an allergic-type reaction. Cosentyx should not be given to people with a previous allergic reaction to Cosentyx or any of its excipients.
• People being treated with Cosentyx are at a higher risk of developing inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fever, blood in the stool, or weight loss.
• Cosentyx is only available as an injection that is administered under the skin. It must be stored in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) before use. Cosentyx does not contain preservatives, and the manufacturer advises that the pre-filled syringe or SensoReady pen should be thrown away if stored unrefrigerated for a single period of more than 4 days at room temperature, not above 30°C. Throw Cosentyx away if it has been left out of the fridge for more than 4 days. Cosentyx does not contain preservatives and microbial contamination may also occur with improper storage conditions.
• Natural rubber latex is contained in the removable cap of the Cosentyx Sensoready pen and the Cosentyx prefilled syringe. This may cause an allergic reaction in latex-sensitive individuals if they handle the cap.
• It is unknown what effect Cosentyx has during pregnancy on the unborn child. There are no data on the effect of Cosentyx during lactation.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• If you have been shown how to self-inject Cosentyx, administer yourself a dose once every month, preferably on the same day of the month, otherwise see your healthcare provider for a dose every month. If you forget a dose, schedule it in for as soon as you can, then continue with your regular dosing schedule. Do not attempt to self-inject Cosentyx if you have not been shown how to do so by a health professional.
• Immediately before administration take one or two (depending on if your dose is 150mg or 300mg) Cosentyx injections out of the refrigerator and leave on a flat surface, away from children and pets, to warm up to room temperature for 15 to 30 minutes, no longer. Do not warm in any other way (such as by putting in hot water). Cosentyx at room temperature reduces the risk of stinging. Inspect the injection for any discoloration or particulate matter and do not use if the liquid is cloudy, contains particles, or is discolored. The liquid in Cosentyx should be clear, colorless, or have a slightly yellow tinge. Check the expiry date on the side of the injection and do not use Cosentyx if it has expired. Do not shake Cosentyx.
• Cosentyx is best administered into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay and inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm. Change your injection site each month so that you are not injecting into the same spot each time.
• Only inject into clear, healthy skin. Do not inject into any areas that are bruised, tender, red, scaly, or hard. You should also not inject into any scars, stretch marks, or areas of psoriasis.
• If you feel pain when you inject Cosentyx, placing an ice pack on the area of the skin where you inject Cosentyx for a few minutes before and after the injection can help reduce this pain.
• If you are using the Cosentyx Sensoready pen, do not shake it before use. Wash your hands then clean the injection site with an alcohol wipe and let the area dry. Twist off the cap and discard it. Hold the pen in a fist grip at a 90-degree angle (straight up and down) to your preferred injection site and press firmly against your skin. The pen will click twice. The first click means the injection has started, and you need to keep holding the pen firmly in place. The second click means that the injection has almost finished but you need to still hold the pen in place until all the medicine has dispensed. The medicine has finished dispensing when the green indicator fills the window and has stopped moving. Remove the pen from your skin. Throw away the used pen in an FDA approved sharps container. Each Cosentyx Sensoready Pen contains 150mg of Cosentyx. If your dose is 150mg Cosentyx then use one Cosentyx Sensoready Pen, if your dose is 300mg Cosentyx, then use two pens (one at a time) and repeat the above steps for the second pen.
• If you are using the Cosentyx prefilled syringe, wash your hands then clean the injection site with an alcohol wipe and let the area dry. Remove the needle cap from the Cosentyx prefilled syringe and throw it away. Hold the prefilled syringe in one hand then with the other hand gently pinch the skin at the injection site to form a small bump of skin. Then insert the needle into the small bump at a 45-degree angle, making sure you push the needle in all the way. Now put your first two fingers on the finger grips of the syringe and slowly with your thumb completely push down the plunger as far as it can go. Once it is fully depressed (the plunger head should finish between the syringe guard wings) you should leave the injection in place for another 5 seconds to make sure all of the medicine has been injected. Keeping the plunger pushed in, you can now remove the injection from your skin. Once the injection has been removed from the skin, the plunger can be slowly released which allows the syringe guard to cover the needle. Throw away the used Cosentyx prefilled syringe into an FDA-approved sharps container.
• Store Cosentyx in the refrigerator. Once taken out of the refrigerator, try to use within one hour. If you inadvertently leave it out of the refrigerator for longer, the manufacturer advises that the pre-filled syringe or SensoReady pen may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C. Throw Cosentyx away if it has been left out of the fridge for more than 4 days. Cosentyx does not contain preservatives and microbial contamination may also occur with improper storage conditions. Do not freeze Cosentyx. Protect Cosentyx from light.
• Seek urgent medical attention if you experience shortness of breath, facial or throat tightness after administering Cosentyx. If you feel unwell, or experience other signs of infection, tell your doctor immediately. Also remember to tell your doctor about any other side effects that you may be experiencing, such as dizziness or fainting.
• Cosentyx is associated with a higher risk of developing inflammatory bowel disease. Report any symptoms such as diarrhea, abdominal pain, fever, blood in the stool, or weight loss to your doctor.
• Tell other health professionals that you are being administered Cosentyx. Before you start Cosentyx, all your vaccinations should be up to date. While you are receiving Cosentyx, you should not receive any live vaccines (such as the MMR vaccine or the chickenpox vaccine).
• Cosentyx is not recommended during pregnancy unless the benefits outweigh the risks but tell your doctor immediately if you become pregnant while being administered Cosentyx.
• Talk to your doctor or pharmacist before taking any other medicines with Cosentyx.

• Cosentyx starts working within a few weeks but it may take up to 4 months for the full effects to be seen.
• 77.1% of patients had a 75% reduction in their PASI (Psoriasis Area and Severity Index) score after 12 weeks of administering Cosentyx 300mg. After 16 weeks this had increased to 86.7% of patients.
• For psoriatic arthritis, after 4 weeks, 50% of patients had experienced an ACR 20 (this corresponds to a 20% improvement in psoriatic arthritis). By 16 weeks the number of psoriatic arthritis patients who had reached ARC20 was 62.6 %, and the percentage of patients who had reached ARC50 was 39.6%.
• The FUTURE 5 study showed that 91.8% of psoriatic arthritis patients on Cosentyx 300mg had no radiographic disease progression throughout the 52 weeks studied.
• For Ankylosing Spondylitis (AS), it took 3 weeks for 50% of the patients to have an ASAS20 (20% improvement in AS). The ASAS40 response at 3 weeks is over 20% and by 16 weeks the number of patients who had an ASAS20 response increased up to 61.1% of patients, and the number of patients with an ASAS40 response was 36.1%.
• In the MEASURE 1 study, x rays showed that 79% of AS patients on long-term Cosentyx 150 mg therapy had no definite disease progression.
• For non-radiographic Axial Spondyloarthritis, by 16 weeks 13% of patients had a response of ASAS40 (40% improvement) and this increased to 19% by week 52.

Medicines that interact with Cosentyx may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Cosentyx. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Cosentyx include:

• aminophylline
• anticonvulsants, such as phenobarbital,
• benzodiazepines, such as alprazolam or clonazepam
• chemotherapy agents, such as cyclophosphamide, methotrexate, or bleomycin
• corticosteroids (such as prednisone or dexamethasone)
• cyclosporine
• heart medications such as amiodarone or flecainide
• herbals, such as echinacea
• hormones such as levonorgestrel or norgestrel
• immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus)
• live vaccines and some other non-live vaccines, such as BCG, cholera, measles, or hepatitis b vaccines
• opioids, such as fentanyl or oxycodone
• other biologics, such as adalimumab, golimumab, or infliximab
• probiotics, such as lactobacillus
• statins, such as atorvastatin or simvastatin
• theophylline
• warfarin
• zinc.

There is a potential for any medication that is metabolized by CYP450 enzymes, particularly those with a narrow therapeutic index (such as cyclosporine or warfarin) to interact with Cosentyx. This is because the formation of CYP450 enzymes can be altered by increased levels of certain cytokines (such as IL-1, IL-6, IL-10, Il-17) during chronic inflammation. Because Cosentyx stops IL-17A from interacting with the IL-17 receptor, this could normalize the formation of CYP450 enzymes. Monitor for any changes and consider any dosage modification.

Note that this list is not all-inclusive and includes only common medications that may interact with Cosentyx. You should refer to the prescribing information for Cosentyx for a complete list of interactions.